Renal Denervation Therapy in Hypertensive Patients Undergoing A-Fib Ablation

Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study

We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Atrial Fibrillation
• Intervention / Treatment: Procedure: AF ablation alone; Procedure: AF ablation with Renal Denervation

Detailed Description

Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. Pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal denervation therapy along with AF ablation is associated with improvement in success rates of AF ablation along with adequate control of blood pressure. The specific objectives of this study are to prospectively compare success rates, time to AF recurrence, AF burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with AF ablation alone.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Paroxysmal and Persistent Atrial Fibrillation refractory eligible for AF ablation as per HRS/ECAS/EHRA consensus statement.[23] Paroxysmal AF is defined as two or more episodes of AF lasting less than 7 days in duration during the last 6 months before enrollment. Persistent AF is defined as AF lasting more than 7 days or requiring cardioversion for termination.
2. Hypertension (>140/80 mm Hg) on treatment with at least 1 hypertensive medication.
3. GFR >60ml/dl using Cockcroft- Gault equation

Exclusion Criteria:

1. Secondary causes of hypertension
2. Severe renal artery stenosis or dual renal arteries
3. Congestive heart failure with NYHA class III or IV status
4. EF< 35%
5. LA Diameter >6 cm
6. Previous AF ablation
7. Previous renal artery stent or angioplasty
8. Severe contrast allergy
9. Inability to give informed consent
10. Solitary kidney

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AF Ablation alone; Clinical AF ablation performed as deemed appropriate by operator	Procedure: AF ablation alone; Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.
EXPERIMENTAL: AF ablation with Renal Denervation; Renal denervation performed using the same ablation catheter after clinical AF ablation	Procedure: AF ablation with Renal Denervation; Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques. Both mapping and ablation are performed under general anesthesia. The use of standard electrophysiology ablation catheter to perform renal artery ablation in hypertensive patients has been previously described. UP to 2 minutes of RF energy (10W with irrigation flow of 17 ml/min) are delivered at each location and up to 6 lesions for each artery on the longitudinal and rotational axis. Renal denervation is performed on both vascular pedicles after clinical AF ablation in patients assigned to the intervention arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation (AF) Time to recurrence and Burden	After 3 months of blanking period, time to recurrence of atrial arrhythmia lasting more than 30 seconds is measured during follow up. (Atrial fibrillation)AF burden is assessed on a 7 day duration event monitor. Electrocardiogram (EKG) or Event monitor strips will be evaluated by independent board certified physicians.	1 year
Hypertension control	BP is obtained as per Joint National Committee (JNC 7) standards at 3, 6 and 12 month visits of follow up. Information regarding titration of antihypertensives or reduction in the number of medications to adequately control blood pressure is collected.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Glomerular Filtration Rate (GFR) at 3, 6 and 12 months	1 year
Renal artery complications by Crosssectional Imaging (Magnetic Resonance Imaging or computed tomography	3months
Quality of life scores (MAFSI- Mayo Atrial Fibrillation Symptom Index)	1 year
Change in left atrial volume parameters	1 year

Collaborators and Investigators

• Sponsor: Siva Mulpuru
• Investigators: Principal Investigator: Siva K. Mulpuru, M.D., Mayo Clinic, Rochester, MN

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (ESTIMATE): September 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Hypertension; Renal Denervation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: 12-009062